Trial Outcomes & Findings for Amlodipine Plus Botulinum Toxin for Focal Dystonia (NCT NCT00015457)

Results Overview

Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

1-2 month maximal rating

Results posted on

2013-04-01

Participant Flow

Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06

Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening

Participant milestones

Participant milestones
Measure	Amlodipine Then Placebo Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.	Placebo Then Amlodipine Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
First Intervention STARTED	8	8
First Intervention COMPLETED	8	5
First Intervention NOT COMPLETED	0	3
Second Intervention STARTED	8	5
Second Intervention COMPLETED	7	5
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Amlodipine Then Placebo Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.	Placebo Then Amlodipine Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
First Intervention Adverse Event	0	2
First Intervention Lack of Efficacy	0	1
Second Intervention Withdrawal by Subject	1	0

Baseline Characteristics

Amlodipine Plus Botulinum Toxin for Focal Dystonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Dystonia n=16 Participants All participants enrolled in study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 month maximal rating

Population: Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data

Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.

Outcome measures

Outcome measures
Measure	Amlodipine n=11 Participants Patients receiving Amlodipine plus botulinum toxin injections during either period.	Placebo n=11 Participants Patients receiving Placebo plus botulinum toxin injections during either period.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score	-6.00 units on a scale Standard Deviation 10.23	-3.23 units on a scale Standard Deviation 6.06

SECONDARY outcome

Timeframe: 3 months

Population: Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.

Self reported duration of effect in weeks.

Outcome measures

Outcome measures
Measure	Amlodipine n=11 Participants Patients receiving Amlodipine plus botulinum toxin injections during either period.	Placebo n=11 Participants Patients receiving Placebo plus botulinum toxin injections during either period.
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo	6 weeks Interval 1.0 to 12.0	5.5 weeks Interval 2.0 to 12.0

Adverse Events

Amlodipine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amlodipine n=16 participants at risk Patients receiving Amlodipine plus botulinum toxin injections during either period.	Placebo n=16 participants at risk Patients receiving Placebo plus botulinum toxin injections during either period.
Blood and lymphatic system disorders hypereosinophila	6.2% 1/16 • Number of events 1	0.00% 0/16
General disorders dysphagia	0.00% 0/16	6.2% 1/16 • Number of events 1
Skin and subcutaneous tissue disorders swelling	6.2% 1/16 • Number of events 1	6.2% 1/16 • Number of events 1

Additional Information

Barbara I Karp, MD

National Institutes of Health

Phone: 301-496-0150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place