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Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00068445
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Neurotoxicity
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: lamotrigine
Other: Placebo

  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
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Reporting Groups
  Description
Arm I - Lamotrigine Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Arm II - Placebo Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.

Participant Flow for 2 periods

Period 1:   Randomization
    Arm I - Lamotrigine   Arm II - Placebo
STARTED   65   66 
COMPLETED   63   62 
NOT COMPLETED   2   4 
Cancel                1                3 
Ineligible                1                1 

Period 2:   Treatment
    Arm I - Lamotrigine   Arm II - Placebo
STARTED   63   62 
COMPLETED   34   46 
NOT COMPLETED   29   16 
Refused Further Treatment                13                10 
Adverse Event                7                1 
Other (Specifics not available)                9                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I - Lamotrigine Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Arm II - Placebo Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Arm I - Lamotrigine   Arm II - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   62   125 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (29 to 84) 
 59 
 (34 to 82) 
 61 
 (29 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  57.1%      38  61.3%      74  59.2% 
Male      27  42.9%      24  38.7%      51  40.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   63   62   125 


  Outcome Measures

1.  Primary:   Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)   [ Time Frame: From baseline to week 10 ]

2.  Primary:   Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)   [ Time Frame: From baseline to week 10 ]

3.  Secondary:   The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10   [ Time Frame: From baseline to week 10 ]

4.  Secondary:   Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

5.  Secondary:   Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

6.  Secondary:   Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

7.  Secondary:   Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

8.  Secondary:   Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

9.  Secondary:   Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]

10.  Secondary:   Change in POMS Total Score [Week 10 Minus Baseline]   [ Time Frame: From baseline to week 10 ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
phone: 507-284-3731
e-mail: cloprinzi@mayo.edu


Publications of Results:
Renno SI, Rao RD, Sloan J, et al.: The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3. [Abstract] J Clin Oncol 24 (Suppl 18): A-8530, 475s, 2006.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00068445     History of Changes
Other Study ID Numbers: NCCTG-N01C3
CDR0000322830 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: February 6, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018