This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

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1 abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical study report had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country.. Additional information on this study and the drug concerned may be provided upon request based on Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of Boehringer Ingelheim.

2 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 1 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Title of trial: A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of pramipexole IR ( mg/day) versus placebo for 6 weeks in children and adolescents (age 6-17 inclusive) diagnosed with Tourette s Disorder according to DSM-IV criteria Coordinating MD Investigator: Trial sites: Multicentre study, cf. Appendix Publication (reference): Clinical phase: Objectives: Methodology: No. of subjects: planned: Enrolled: 62 Results of this trial have not yet been published II Efficacy of pramipexole versus placebo, investigation of safety and tolerability, pharmacokinetics of pramipexole Randomized, double-blind, placebo-controlled, flexible dose, parallel group study entered: 60 actual: enrolled: 68 entered: 63 Treatment pramipexole (tablets of mg, mg and 0.25 mg): entered: 43 treated: 43 analysed (for primary endpoint): 42 Treatment placebo tablets matching pramipexole: entered: 20 treated: 20 analysed (for primary endpoint): 20

3 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 2 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Diagnosis and main criteria for inclusion: Test product: dose: Male or female patients 6-17 years of age, diagnosed with Tourette s Disorder according to DSM-IV criteria, and with a score 22 on the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS) Pramipexole (tablets of mg, mg and 0.25 mg) Flexible dose of Pramipexole Starting dose mg bid, with possible down titration after one week to mg qd or optional up titration to mg bid, after the second week optional up titration to mg tid, after the third week optional up titration to 0.25 mg bid Per os mode of admin.: batch no.: Reference therapy: tablets matching the Pramipexole tablets dose: mode of admin.: Per os batch no.: B ( matching placebo) (0.125 matching placebo) U (0.25 matching placebo) Duration of treatment: Total treatment duration of 6 weeks followed by up to a 3 day down-titration phase.

4 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 3 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Criteria for evaluation: Efficacy / clinical pharmacology: Primary efficacy endpoint Change from baseline in the TTS of the YGTSS after 6 weeks of treatment Secondary efficacy endpoints Change from baseline in the total score of the YGTSS after 6 weeks of treatment Change from baseline in TTS and total score of the YGTSS at Weeks 1, 2, 3, and 4 CGI-S response based on the change from baseline at Week 1, 2, 3, 4 and 6 CGI-I responder rate ( much and very much improved ) at Weeks 1, 2, 3, 4 and 6 PGI-I responder rate ( much and very much better ) at Weeks 1, 2, 3, 4 and 6 Pharmacokinetics of pramipexole

5 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 4 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Safety: Incidence of adverse events, proportion of withdrawals due to adverse events, vital signs (blood pressure, orthostatic reaction and pulse rate), height, weight, Tanner Staging, ECG assessments as well as safety laboratory parameters, blood hematology and electrolyte assessments, serum chemistry and urine analyses at baseline and at the end of the treatment period. Change from baseline at the end of treatment visit (Week 6) in the DuPaul ADHD rating scale IV Change from baseline at Weeks 1, 2, 3, 4 and 6 in the Children's Yale- Brown Obsessive Compulsive Scale (CY-BOCS) Obsessive Subscore, Compulsive Score, and Total Score MASC change from baseline at Week 6 Change from baseline at the end of treatment visit (Week 6) in the Child Depression Inventory-Short Version (CDI-S) Change from baseline at the end of treatment visit (Week 6) in the subscores of the Child Behavior Checklist for 6-18 year olds (CBCL/6-18) Change from baseline at the end of treatment visit (Week 6) in specific CBCL/6-18 questions related to impulse control and suicidality/homicidal ideation

6 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 5 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Statistical methods: Primary analysis Analysis of covariance (ANCOVA) including the main effects of treatment, centre (pooled), and age group (<13 and 13 years old), with baseline TTS as a covariate to evaluate the change from baseline in TTS after 6 weeks of treatment (LOCF). Secondary analyses: Repeated measures analysis evaluating treatment effects on the change from baseline in TTS over the course of the trial. ANCOVA, analogous to the primary analysis of the primary endpoint, to evaluate treatment effects on the change from baseline in the total score of the YGTSS Cochran-Mantel-Haenszel (CMH) test stratified by age group to evaluate response based on CGI-S, CGI-I, and PGI-I Pharmacokinetics Plasma concentrations at trough (C pre,ss ) and 2 h post-dose (C 2,ss ) were collected at Visit 6 and Visit 7 at steady-state. The pramipexole plasma concentrations were compared descriptively with respect to age, gender and creatinine clearance.

7 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Module: Tabulated Trial Report EudraCT No.: Page: 6 of 7 Volume: {hyperlink } ABCD Synopsis No.: Report date: 15 DEC 2009 Trial No. / U No.: / U Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. SUMMARY CONCLUSIONS: Efficacy / clinical pharmacology results Efficacy For the primary endpoint of the change from baseline in TTS following six weeks of treatment, when analysing the full analysis set there was no significant difference found (p=0.9960) between the adjusted mean changes for patients treated with pramipexole (-7.16) and placebo (-7.17). This lack of significant difference for the primary endpoint between treatment with pramipexole and placebo was confirmed when analysing the per-protocol set (: and placebo: ; p=0.2503) and from a repeated measures analysis involving all observed TTS values over the course of treatment (: -5.5 and placebo: -6.2; p=0.4166) with no significant treatment-by-week interaction (p=0.9605). Results comparing treatment with pramipexole and placebo for the secondary endpoint of the change from baseline in the total score of the YGTSS as well as the secondary endpoints of response to CGI-S, CGI-I, and PGI-I over the course of treatment found no significant differences between treatment with pramipexole and placebo. Pharmacokinetics Most patients were on a dose of 0.25 mg pramipexole bid, 77% of the patients in the PK dataset at Visit 6 and 70% at Visit 7. Plasma concentrations at trough (C pre,ss ) and 2 hours post dose (C 2,ss ) showed a small intra-individual variability between visits for all dose groups. Combining the dose normalized values for the three bid dosing regimens ( mg bid, mg bid and 0.25 mg bid) at both visits, C pre,ss,norm and C 2,ss,norm were lower in the group of adolescents (age 12 to <18 years) compared to children (age 6 to < 12 years) on average by 27 % and 31%, respectively. C pre,ss,norm and C 2,ss,norm values were both dependent on renal function, depicted as CL CR. C pre,ss,norm values of the bid dosing regimens were not affected by gender, whereas a slight reduction of C 2,ss,norm values by about 16 % were observed in males. Pramipexole exposure in this trial was compared to exposure in a previous trial with pediatric Restless Legs Syndrome (RLS) patients. Exposure of pramipexole in pediatric patients with Tourette s Disorder was comparable to the exposure in pediatric patients with RLS.

8 Name of company: Boehringer Ingelheim Name of finished product: Pramipexole (Sifrol, Mirapex, Mirapexin, Pexola ) Name of active ingredient: Pramipexole dihydrochloride monohydrate Tabulated Trial Report EudraCT No.: Page: 7 of 7 ABCD Synopsis No.: Module: Report date: 15 DEC 2009 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 22 JAN JUN 2009 Date of revision: Not applicable Proprietary confidential information 2014 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Safety results: There were no deaths reported during this trial and no SAEs reported for the pramipexole treatment group. Investigator defined drug related AEs occurred in 17 (39.5%) pramipexole patients and 5 (25.0%) placebo patients. Adverse Events leading to discontinuation of trial medication were reported for 2 (4.7%) pramipexole patients and 1 (5.0%) placebo patient. The most frequently occurring AE in the pramipexole treatment group during this trial was headache (pramipexole, 27.9%; placebo, 25.0%), followed by nausea (pramipexole, 18.6%; placebo, 10.0%), vomiting (pramipexole, 11.6%; placebo, 0.0%), myalgia (pramipexole, 9.3%; placebo, 5.0%), fatigue (pramipexole, 9.3%; placebo, 10.0%), and orthostatic hypotension (pramipexole, 9.3%; placebo, 5.0%). There was only one severe AE, enuresis, that occurred in a patient receiving pramipexole; severe AEs occurred in two patients receiving placebo. There was no evidence of a treatment effect of pramipexole on laboratory values, height, weight, Tanner Staging scores, CY-BOCS, CBCL/6-18, MASC or CDI-S scores over the 6 weeks of treatment. There was some evidence of more improvement in DuPaul ADHD scores for patients receiving pramipexole (decrease from baseline: -10.8) compared with placebo (decrease from baseline: -4.0). Conclusions: There was no evidence for the efficacy of pramipexole for treatment of tics associated with Tourette s Disorder in this trial. Results consistently did not support efficacy over placebo across the primary and all secondary efficacy endpoints. Pramipexole was generally well-tolerated in this trial, with no notable safety signals or concerns. The PK analysis confirmed exposure to pramipexole in this pediatric Tourette s Disorder patient population. The PK of pramipexole appeared to be dependent on renal function and age but not on gender.

9 Boehringer Ingelheim BI trial number Trial Synopsis - Appendix c Trial Synopsis Appendix The appended tables on the following pages supplement the trial results presented in the trial synopsis. They complement disposition results and results for secondary endpoints of the trial. Results for Presented in Patient disposition Table : 2 Change from Baseline to Week 1, 2, 3 and 4 in TTS of YGTTS Table : 1 Change from Baseline to Week 6 in Total YGTTS Table : 2 CGI-S response based on change from baseline at Weeks 1, 2, 3, 4, and 6 1 Table : 1 CGI-I responder rate at Weeks 1, 2, 3, 4, and 6 2 Table : 1 PGI-I responder rate at Weeks 1, 2, 3, 4, and 6 3 Table : 1 1 Improved = CGI-S change of -2; Unchanged = CGI-S change of -1, 0, or +1; Worsened = CGI-S change of 2 2 CGI-I responders: patients with a CGI-I of Very much improved or Much improved 3 PGI-I responders: patients with a PGI-I of Very much better or Much better

10 Boehringer Ingelheim Page 124 Table : 2 Patient disposition by randomised treatment group Total Disposition N (%) N (%) N (%) Enrolled 68 Not Entered 5 Entered Not Treated Treated 20 (100.0) 43 (100.0) 63 (100.0) Not Prematurely Discontinued 19 ( 95.0) 39 ( 90.7) 58 ( 92.1) Prematurely Discontinued 1 ( 5.0) 4 ( 9.3) 5 ( 7.9) Adverse Events 1 ( 5.0) 2 ( 4.7) 3 ( 4.8) Worsening of Disease Under Study 0 ( 0.0) 1 ( 2.3) 1 ( 1.6) Worsening of Other Pre existing Disease 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Other Adverse Event 1 ( 5.0) 1 ( 2.3) 2 ( 3.2) Administrative 0 ( 0.0) 1 ( 2.3) 1 ( 1.6) Lack of efficacy 0 ( 0.0) 1 ( 2.3) 1 ( 1.6) Non Compliant with Protocol 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Lost to Follow Up 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Patient refused to Continue medication 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Other 0 ( 0.0) 1 ( 2.3) 1 ( 1.6) Source data: Appendix 16.2, Listing 1.2 t15disp.sas 26AUG2009

11 Boehringer Ingelheim Page 201 Table : 1 Summary of observed change from baseline over the course of the trial in TTS by randomised treatment group (FAS) Change Change from from Observed baseline Observed baseline Week 0 (Baseline) N Mean SD Minimum Median Maximum Week 1 N Mean SD Minimum Median Maximum Week 2 N Mean SD Minimum Median Maximum Week 3 N Mean SD Minimum Median Maximum Week 4 N SD Standard deviation Source data: Appendix 16.2, Listing 3.1, 6.1 t15tab2.sas 26AUG2009

12 Boehringer Ingelheim Page 202 Table : 1 Summary of observed change from baseline over the course of the trial in TTS by randomised treatment group (FAS) Change Change from from Observed baseline Observed baseline Mean SD Minimum Median Maximum Week 6 N Mean SD Minimum Median Maximum SD Standard deviation Source data: Appendix 16.2, Listing 3.1, 6.1 t15tab2.sas 26AUG2009

13 Boehringer Ingelheim Page 197 Table : 2 Analysis comparing treatment effects on change from baseline to end of treatment visit (LOCF) in the total score of the YGTSS (FAS) Treatment LSMean StdErr 95% CI p value ( 21.66, 9.50) ( 24.31, 6.54) Difference 0.15 ( 11.05, 10.75) Source data: Appendix 16.2, Listing 3.1, 4.1.1, 4.2.1, 6.1 t15glm1.sas 26AUG2009

14 Boehringer Ingelheim Page 206 Table : 1 Frequency distributions of categorizations based on change from baseline in CGI S over the course of the trial (LOCF) by randomised treatment group (FAS) Week 1 CGI S Category N (%) N (%) Improved 0 ( 0.0) 4 ( 9.5) Unchanged 20 (100.0) 38 ( 90.5) Worsened 0 ( 0.0) 0 ( 0.0) p= Source data: Appendix 16.2, Listing 3.1, 6.2 t15freq.sas 26AUG2009

15 Boehringer Ingelheim Page 207 Table : 1 Frequency distributions of categorizations based on change from baseline in CGI S over the course of the trial (LOCF) by randomised treatment group (FAS) Week 2 CGI S Category N (%) N (%) Improved 1 ( 5.0) 4 ( 9.5) Unchanged 19 ( 95.0) 37 ( 88.1) Worsened 0 ( 0.0) 1 ( 2.4) p= Source data: Appendix 16.2, Listing 3.1, 6.2 t15freq.sas 26AUG2009

16 Boehringer Ingelheim Page 208 Table : 1 Frequency distributions of categorizations based on change from baseline in CGI S over the course of the trial (LOCF) by randomised treatment group (FAS) Week 3 CGI S Category N (%) N (%) Improved 3 ( 15.0) 4 ( 9.5) Unchanged 17 ( 85.0) 37 ( 88.1) Worsened 0 ( 0.0) 1 ( 2.4) p= Source data: Appendix 16.2, Listing 3.1, 6.2 t15freq.sas 26AUG2009

17 Boehringer Ingelheim Page 209 Table : 1 Frequency distributions of categorizations based on change from baseline in CGI S over the course of the trial (LOCF) by randomised treatment group (FAS) Week 4 CGI S Category N (%) N (%) Improved 4 ( 20.0) 4 ( 9.5) Unchanged 16 ( 80.0) 38 ( 90.5) Worsened 0 ( 0.0) 0 ( 0.0) p= Source data: Appendix 16.2, Listing 3.1, 6.2 t15freq.sas 26AUG2009

18 Boehringer Ingelheim Page 210 Table : 1 Frequency distributions of categorizations based on change from baseline in CGI S over the course of the trial (LOCF) by randomised treatment group (FAS) Week 6 CGI S Category N (%) N (%) Improved 4 ( 20.0) 10 ( 23.8) Unchanged 16 ( 80.0) 32 ( 76.2) Worsened 0 ( 0.0) 0 ( 0.0) p= Source data: Appendix 16.2, Listing 3.1, 6.2 t15freq.sas 26AUG2009

19 Boehringer Ingelheim Page 212 Table : 1 Response rates based on CGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 1 CGI I Responder N (%) N (%) Yes 0 ( 0.0) 5 ( 11.9) No 20 (100.0) 37 ( 88.1) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

20 Boehringer Ingelheim Page 213 Table : 1 Response rates based on CGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 2 CGI I Responder N (%) N (%) Yes 1 ( 5.0) 6 ( 14.3) No 19 ( 95.0) 36 ( 85.7) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

21 Boehringer Ingelheim Page 214 Table : 1 Response rates based on CGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 3 CGI I Responder N (%) N (%) Yes 2 ( 10.0) 5 ( 11.9) No 18 ( 90.0) 37 ( 88.1) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

22 Boehringer Ingelheim Page 215 Table : 1 Response rates based on CGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 4 CGI I Responder N (%) N (%) Yes 7 ( 35.0) 6 ( 14.3) No 13 ( 65.0) 36 ( 85.7) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

23 Boehringer Ingelheim Page 216 Table : 1 Response rates based on CGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 6 CGI I Responder N (%) N (%) Yes 7 ( 35.0) 11 ( 26.2) No 13 ( 65.0) 31 ( 73.8) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

24 Boehringer Ingelheim Page 218 Table : 1 Response rates based on PGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 1 PGI I Responder N (%) N (%) Yes 4 ( 20.0) 7 ( 16.7) No 16 ( 80.0) 35 ( 83.3) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

25 Boehringer Ingelheim Page 219 Table : 1 Response rates based on PGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 2 PGI I Responder N (%) N (%) Yes 6 ( 30.0) 9 ( 21.4) No 14 ( 70.0) 33 ( 78.6) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

26 Boehringer Ingelheim Page 220 Table : 1 Response rates based on PGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 3 PGI I Responder N (%) N (%) Yes 5 ( 25.0) 7 ( 16.7) No 15 ( 75.0) 35 ( 83.3) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

27 Boehringer Ingelheim Page 221 Table : 1 Response rates based on PGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 4 PGI I Responder N (%) N (%) Yes 4 ( 20.0) 7 ( 16.7) No 16 ( 80.0) 35 ( 83.3) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

28 Boehringer Ingelheim Page 222 Table : 1 Response rates based on PGI I over the course of the trial (LOCF) by randomised treatment group (FAS) Week 6 PGI I Responder N (%) N (%) Yes 6 ( 30.0) 12 ( 28.6) No 14 ( 70.0) 30 ( 71.4) p= Source data: Appendix 16.2, Listing 3.1, 6.3 t15freq.sas 26AUG2009

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

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