Comparison of Keppra and Clonidine in the Treatment of Tics - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Tic Disorders Tourette Syndrome
Interventions:	Drug: Levetiracetam Drug: Clonidine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 participants signed informed consent, but 2 participants were never randomized to treatment arm.

Reporting Groups

	Description
First Levetiracetam Then Clonidine	Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day). In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day). Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study. Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).
Clonidine First, Then Levetiracetam	Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)). In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day). Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study. Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).

Description

First Levetiracetam Then Clonidine

Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).

In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).

Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.

Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).

Clonidine First, Then Levetiracetam

Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).

In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).

Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.

Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).

Participant Flow for 4 periods

Period 1: Period 1 (Days 8-50)

	First Levetiracetam Then Clonidine	Clonidine First, Then Levetiracetam
STARTED	7	3
COMPLETED	7	3
NOT COMPLETED	0	0

Period 2: Washout (Days 51-64)

	First Levetiracetam Then Clonidine	Clonidine First, Then Levetiracetam
STARTED	7	3
COMPLETED	7	3
NOT COMPLETED	0	0

Period 3: Period 2 (Days 65-107)

	First Levetiracetam Then Clonidine	Clonidine First, Then Levetiracetam
STARTED	7	3
COMPLETED	7	3
NOT COMPLETED	0	0

Period 4: Taper

	First Levetiracetam Then Clonidine	Clonidine First, Then Levetiracetam
STARTED	7	3
COMPLETED	7	3
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Levetiracetam First, Then Clonidine	Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day). In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day). Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study. Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).
Clonidine First, Then Levetiracetam	Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)). In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day). Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study. Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).
Total	Total of all reporting groups

Description

Levetiracetam First, Then Clonidine

Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).

In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).

Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.

Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).

Clonidine First, Then Levetiracetam

Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).

In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).

Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.

Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above).

Total

Total of all reporting groups

Baseline Measures

	Levetiracetam First, Then Clonidine	Clonidine First, Then Levetiracetam	Total
Number of Participants [units: participants]	7	3	10
Age [units: participants]
<=18 years	6	2	8
Between 18 and 65 years	1	1	2
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	14.5 ± 6.4	16.0 ± 4.4	14.9 ± 5.5
Gender [units: participants]
Female	1	2	3
Male	6	1	7
Region of Enrollment [units: participants]
United States	7	3	10

Outcome Measures

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1. Primary:

Yale Global Tic Severity Scale (YGTSS): [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

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2. Primary:

Total Tic Score [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

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3. Secondary:

Clinical Global Impression-Improvement (CGI-I): [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

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4. Secondary:

Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS): [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

Show Outcome Measure 4

5. Secondary:

DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale: [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

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6. Secondary:

Multidimensional Anxiety Scale for Children (MASC): [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

Show Outcome Measure 6

7. Secondary:

Modified Pittsburgh Side Effect Scale [ Time Frame: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Harvey Singer
Organization: Johns Hopkins University
phone: 410-955-7212
e-mail: hsinger@jhmi.edu

No publications provided

Responsible Party:	Harvey S. Singer, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00370838 History of Changes
Other Study ID Numbers:	TSkepclon
Study First Received:	August 30, 2006
Results First Received:	June 22, 2011
Last Updated:	September 1, 2011
Health Authority:	United States: Institutional Review Board